Regulatory Education for Industry (REdI): Clinical Investigator Training Course - Nov. 12-14, 2019

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<ol class="lcds-breadcrumb visible-sm visible-xs"> <li> <a href="/drugs/development-approval-process-drugs/cder-small-business-industry-assistance-sbia" title="CDER Small Business & Industry Assistance (SBIA)"> CDER Small Business & Industry Assistance (SBIA) </a> </li> </ol> </section> <main> <article id="main-content" class="article main-content container-fluid" role="article"> <header class="row content-header" role="heading" aria-level="1"> <section id="block-entityviewcontent-2" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="col-sm-12 col-md-8 col-md-offset-2"> <h1 class="content-title text-center">Regulatory Education for Industry (REdI): Clinical Investigator Training Course - Nov. 12-14, 2019</h1> <div class="lcds-toolbar lcds-toolbar--social"> <ul class="lcds-share lcds-share--default"> <li class="lcds-share__item"> <a 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Post </a> </li> <li class="lcds-share__item hidden-xs"> <a href="https://www.linkedin.com/shareArticle?mini=true&url=https://www.fda.gov%2Fdrugs%2Fcder-small-business-industry-assistance-sbia%2Fregulatory-education-industry-redi-clinical-investigator-training-course-nov-12-14-2019&title=Regulatory%20Education%20for%20Industry%20%28REdI%29%3A%20Clinical%20Investigator%20Training%20Course%20-%20Nov.%2012-14%2C%202019&source=FDA" class="lcds-share__btn lcds-share--default__btn-linkedin js-share" id="linkedin-share" target="_blank"><span class="fa icon-linkedin" aria-hidden="true"></span>Linkedin</a> </li> <li class="lcds-share__item"> <a href="mailto:?subject=Regulatory%20Education%20for%20Industry%20%28REdI%29%3A%20Clinical%20Investigator%20Training%20Course%20-%20Nov.%2012-14%2C%202019&body=https://www.fda.gov%2Fdrugs%2Fcder-small-business-industry-assistance-sbia%2Fregulatory-education-industry-redi-clinical-investigator-training-course-nov-12-14-2019" class="lcds-share__btn 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Time</strong></div> <div class="panel-body" style="text-align: center;">November 12-14, 2019<br> <br> Tuesday, Wednesday,Thursday</div> </div> </div> <div class="col-sm-2 col-md-6"> <div class="panel panel-primary"> <div class="panel-heading" style="text-align: center;"><strong>Location </strong></div> <div class="panel-body" style="text-align: center;"><a href="https://www.thehotelumd.com/">The Hotel at the University of Maryland</a><br> College Park, MD</div> </div> </div> </div> <p style="text-align: center;"> </p> <p style="text-align: center;"><strong><a class="btn btn-primary" href="https://cersi.umd.edu/clinical-investigator-training-course/nov-2019">View Course Slides and Recordings</a>  </strong> <strong><a class="btn btn-primary" data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="fabe18cf-5221-4b08-8570-6de32f65f5b8" href="/media/130054/download?attachment" title="CITC Clinical Investigator Training Course Nov 12-14 2019">Agenda</a></strong></p> <p>This course provides a study of clinical trial principles with in-depth coverage of clinical trial design, issues in safety and efficacy, investigator responsibilities, understanding the investigator brochure, and FDA requirements across Centers.<br> Upon completion, attendees should understand pre-clinical research, clinical trials, and FDA submissions for licensure of medical products. <strong>   </strong></p> <h3><strong>About the Training Course </strong></h3> <p>Topics include:</p> <ul> <li>Clinical trial design and analysis, including new trends and key documents such as: protocol, informed consent, investigator鈥檚 brochure, health records, and study reports</li> <li>Safety and efficacy requirements</li> <li>Ethical considerations</li> <li>FDA regulatory requirements related to the performance and evaluation of clinical studies</li> <li>Non-clinical, early and advanced clinical studies</li> <li>Roles and responsibilities of the investigator</li> <li>Rationale for Good Clinical Practice (GCP), FDA regulations and inspections</li> <li>Basic statistical principles</li> </ul> <h3><strong>Who Should Attend? </strong></h3> <p><em>To maximize value of this course, we recommend attendees possess a basic understanding of clinical trials, regulatory requirements and medical product development.</em><br> Those who are involved in the clinical trial enterprise and are:</p> <ul> <li>Healthcare professionals (physicians, nurses, and pharmacists, clinical scientists)</li> <li>Consultants</li> <li>Drug, device, and biologic industry employees</li> <li>Regulatory affairs professionals</li> <li>Biomedical professionals</li> </ul> <h3><strong>Learning Objectives </strong></h3> <ul> <li>Explain the responsibilities of an investigator conducting a clinical trial.</li> <li>Describe what to look for in drugs being studied in a clinical trial.</li> <li>Describe the basic concepts of clinical trial design.</li> <li>Review clinical data for sources of bias and error.</li> </ul> <h3><strong>Speakers </strong></h3> <p>Speakers include subject matter experts from CDER, CBER, and CDRH, academia, and representatives from patient advocacy organizations.<strong> </strong></p> <h3><strong>Resources </strong></h3> <ol> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="c77c6467-6e10-46f7-9969-614ed9ad367e" href="/science-research/advancing-regulatory-science/centers-excellence-regulatory-science-and-innovation-cersis" title="Centers of Excellence in Regulatory Science and Innovation (CERSIs)">Centers of Excellence in Regulatory Science and Innovation (CERSI)</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="2324b6a7-e5ea-4d8c-82f7-2b70452b28a9" href="/drugs/cder-small-business-industry-assistance-sbia/regulatory-education-industry-redi-clinical-investigator-training-course-citc-2018-11132018" title="Regulatory Education for Industry (REdI): Clinical Investigator Training Course (CITC) 2018 - 11/13/2018">2018 Clinical Investigator Training Course</a></li> </ol> <h3><strong>Questions </strong></h3> <p>E-mail <a href="mailto:ClinicalInvestigator@fda.hhs.gov">ClinicalInvestigator@fda.hhs.gov</a> or call 301-796-8946.</p> <h3><strong>Continuing Education </strong></h3> <p>This course:</p> <ul> <li>SOCRA accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.</li> <li>has been pre-approved by RAPS as eligible for up to 12 credits towards a participant鈥檚 RAC recertification upon full completion.</li> <li>has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant鈥檚 RQAP re-registration.</li> <li>has been approved by ACRP for medical education credits. Contact hours are provided at 1 unit for at least 45 minutes of qualified material.</li> </ul> <h3><strong>M-CERSI </strong></h3> <p><em>The </em><a href="http://cersi.umd.edu/" target="_blank">University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI)</a>, University of Maryland, and the FDA have partnered to modernize and improve the ways drugs and medical devices are reviewed and evaluated for licensure.  </p>   </div> <aside class="col-md-2 col-md-push-2" role="complementary"> <section id="block-entityviewcontent-4" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <aside class="lcds-card lcds-card--border-top"> <ul role="menu" class="lcds-description-list"> <li role="menuitem" class="node-current-date lcds-description-list__item"> <div> <h2 class="lcds-description-list__item-heading">Content current as of:</h2> <p class="lcds-description-list__item-text"><time 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